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NuFACE Trinity

by Carol Cole Company dba NuFACE

510(k) K181008

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181008 Date11 Oct 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NFO
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NuFACE Trinity is a stimulator, transcutaneous electrical, for aesthetic purposes. It is a device classified under product code NFO and regulation number 882.5890, with a device class of 2.

It received FDA 510(k) clearance (K181008) on October 11, 2018, as substantially equivalent to a predicate device. The device is manufactured by Carol Cole Company dba NuFACE and is intended for use in aesthetic applications as defined by its regulatory classification.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the NuFACE Trinity used for?

    The NuFACE Trinity is a transcutaneous electrical stimulator intended for aesthetic purposes, as defined by its regulatory classification under product code NFO and regulation number 882.5890.

  • What regulatory pathway was used for the NuFACE Trinity?

    The NuFACE Trinity received FDA 510(k) clearance (K181008) on October 11, 2018, as substantially equivalent to a predicate device, following a traditional review process.

  • Who manufactures the NuFACE Trinity and where is it based?

    The NuFACE Trinity is manufactured by Carol Cole Company dba NuFACE, located at 1325 Sycamore Ave., Suite A, Vista, CA 92081, United States.